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Muro 128 5% Ointment (2014-06-02)

Starting date:
June 2, 2014
Posting date:
June 18, 2014
Type of communication:
Drug Recall
Subcategory:
Natural health products
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-40021

Recalled Products

Muro 128 5% Ointment

Reason

Global Safety and Vigilance signal alert associated with an Adverse Drug Event with an observed increase in complaints associated with gritty, sand like feeling in the eye.
Sample analysis revealed crystal precipitates in the product.

Depth of distribution

Retailers, pharamcies, clinics in Ontario, Manitoba, Alberta, British Columbia, Quebec, Newfoundland, New Brunswick Saskatchewan and Nova Scotia

Affected products

Muro 128 5% Ointment

DIN, NPN, DIN-HIM
NPN 00750816
Dosage form

Ointment

Strength

Sodium Chloride - 5% (50.0 mg/g)

Lot or serial number

146931, 153621, 160911, 162421, 169272, 174881, 176931, 182771, 186721, 190181

Companies
Recalling Firm
Bausch & Lomb Canada Inc.
520 Applewood Crescent
Vaughan
L4K 4B4
Ontario
CANADA
Marketing Authorization Holder
Bausch & Lomb Inc.
8500 Hidden River Parkway
Tampa
33637
Florida
UNITED STATES